TMS for Post Stroke Depression

Not Applicable

Completed

• Conditions: Post-stroke Depression
• Interventions: Device: TMS

• Registration Number: NCT04093843
• Lead Sponsor: Amelia Adcock

Brief Summary

The purpose of this study is to find alternative treatments for patient's suffering from depression after having a stroke.This study aims to show that accelerated rTMS is a safe, effective,and convenient treatment for patient's suffering from post-stroke depression in the acute to subacute phase. This will be an open label trial and thus all participants will receive the active rTMS intervention.

Detailed Description

The primary objectives of this project are as follows:

1. To assess the efficacy TMS in PSD. We hypothesize that there will be a decrease in the HAMD score in patients receiving TMS

2. To assess the feasibility of an accelerated protocol using rTMS in patients with acute to subacute stroke and co-existing PSD. We hypothesize that the accelerated protocol will promote compliance in our patient population and that the administration of this intervention is feasible.

3. To assess the safety of rTMS in patients with acute to subacute stroke. We hypothesize that the side effects of TMS will be minimal and the therapy will be well-tolerated and safe in individuals with recent strokes and co-existing PSD.

Study Timeline

• Study Start: 2018-10-24
• Study First Submitted: 2019-07-16
• Study First Submitted QC: 2019-09-13
• Study First Posted: 2019-09-18
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Results First Submitted: 2021-10-11
• Status Verified: 2022-04
• Results First Submitted QC: 2022-04-28
• Last Update Submitted: 2022-04-28
• Results First Posted: 2022-04-29
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Between the ages of 22-85 years old
• Radiographic evidence of acute or subacute stroke
• Ischemic stroke diagnosed within the last 2 weeks to 6 months
• HAMD depression score 8 or greater
• Able to provide written informed consent
• Agree to participate in all study procedures

Exclusion Criteria

• Metallic objects or neurostimulators implanted intracranially
• Stroke in the area of stimulation
• Current thoughts of SI or self-harm as assessed by the M.I.N.I. Suicide Scale score > 8
• ASRM (Altman Self Rating Mania Scale) score > 6 (6 or above indicates likelihood of manic symptoms)
• Current use of illicit substances
• Known history of epilepsy or seizure disorder
• Clinically significant EKG abnormalities including QTC prolongation >450 ms in men or >480 ms in women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TMS	TMS	Open label single arm study to determine safety and effectiveness of TMS for post stroke depression

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	12 months following neurostimulation	Count of Adverse Events Reported during follow up
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale	Depressive symptoms will be quantified 12 months after completion of the rTMS stimulation protocol.	Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)

Trial Locations

Locations (1)

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States